Huludao

Researchers are evaluating the combination of BNT324, a B7-H3 antibody-drug conjugate, with BNT327, a bispecific antibody targeting PD-L1 and VEGF, in participants with advanced, metastatic, or relapsed small cell lung cancer SCLC and non-small cell lung cancer NSCLC. This multi-part study aims to find safe doses, optimize treatment, assess preliminary effects, and confirm clinical efficacy in different lung cancer groups. The study includes participants with confirmed lung cancer who have measurable disease and meet specific health criteria. Participants will receive intravenous infusions of BNT324 combined with BNT327 in a dose escalation design to establish two recommended dose levels RP2D and RP2D-1. The study has two parts Part 1 focuses on dose finding in NSCLC and SCLC Part 2 compares these doses in treatment-naive and relapsed lung cancer cohorts, with some randomized groups. Additional participants may join at the optimal dose to further evaluate safety and effectiveness. Participants will undergo screening, followed by treatment, safety follow-up, and long-term survival monitoring. Researchers will assess dose-limiting toxicities, adverse events, treatment interruptions, and response rates using standardized criteria. Outcomes include objective response rate, disease control, progression-free survival, duration of response, and overall survival, with evaluations continuing up to 87 months. Safety is closely monitored during and after treatment, and participants health status is regularly assessed.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immune response, and early clinical effects of BNT3212, both alone and combined with pumitamig, in adults with advanced solid tumors who have exhausted other treatment options. This first-in-human, open-label study includes dose escalation and expansion phases to find the best dose and assess how the treatments work across different tumor types. The study is divided into four parts Part A and Part B focus on BNT3212 as a single therapy, with dose escalation followed by dose expansion in specific tumor types. Parts C and D evaluate the combination of BNT3212 with a fixed dose of pumitamig, again starting with dose escalation and then expansion cohorts. Treatments are given by intravenous infusion, and doses are adjusted to find the maximum tolerated dose and recommended dose for further study. Participants will undergo regular monitoring including safety assessments, blood tests to study drug levels and immune reactions, and imaging to measure tumor response. Researchers will track side effects, treatment interruptions, and response rates over approximately 31 months. The study also measures progression-free and overall survival. Continuous evaluation of safety and clinical data supports participant well-being throughout the trial.

Researchers are evaluating AZD8205, a new antibody drug conjugate, as a possible treatment for advanced or metastatic solid tumors including breast cancer, biliary tract cancer, ovarian, endometrial, and squamous non-small cell lung cancers. This Phase IIIa multi-center, open-label study aims to determine the safety, tolerability, and appropriate dosing of AZD8205 alone or combined with other anticancer agents such as rilvegostomig, saruparib, and AZD9574. The study includes dose escalation and expansion parts to assess anti-tumor activity in select solid tumors. Participants are assigned to one of four sub-studies that involve different combinations of AZD8205 with other drugs. Each sub-study has two parts Part A focuses on dose escalation to find safe doses, and Part B evaluates the anti-tumor effects at the recommended doses. Some sub-studies may add triplet combinations based on safety data and may include future protocol amendments. Treatment is given according to the assigned sub-study and dosing schedules. During the study, participants undergo assessments including monitoring for adverse events, serious adverse events, dose-limiting toxicities, and changes in laboratory tests, ECGs, and vital signs. Researchers also measure responses such as objective response rate, duration of response, progression-free survival, disease control rate, overall survival, pharmacokinetics, and immunogenicity over approximately two years. Study participation includes regular visits for treatment and evaluations, with safety follow-up until 30 days after the last dose.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd with or without Durvalumab compared to investigators choice chemotherapy combined with Pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC. This Phase III, randomized, open-label, international study aims to determine if Dato-DXd with Durvalumab can improve progression-free survival and overall survival while assessing quality of life impacts in this patient population. Participants are assigned to one of three groups Dato-DXd with Durvalumab, investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with Pembrolizumab, or Dato-DXd alone. All study drugs are given by intravenous infusion. The study includes stratification by geographic region, disease-free interval, and prior PD-1PD-L1 treatment. Treatment continues with monitoring up to about 33 months for progression-free survival and safety, with some outcomes followed up to 64 months. Throughout the study, participants undergo assessments including imaging to measure tumor response using RECIST criteria, laboratory tests, and questionnaires to evaluate symptoms and quality of life. Researchers monitor time to disease progression, overall survival, response duration, and safety outcomes. Follow-up includes evaluation of subsequent therapies and pharmacokinetics. The total participation duration can be up to several years to capture long-term outcomes.

Researchers are assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

Researchers are evaluating the efficacy and safety of Dato-DXd in patients with hormone receptor-positive, HER2 IHC 0, locally advanced inoperable or metastatic breast cancer that is resistant to endocrine therapy. This Phase IIIb, single-arm, open-label, multinational study focuses on patients who have not undergone chemotherapy for their metastatic disease. The study aims to understand how Dato-DXd performs in this specific breast cancer group and to assess its impact on disease progression and patient outcomes. Participants will receive Dato-DXd at a dose of 6 mgkg administered intravenously every three weeks, with a maximum dose of 540 mg for participants weighing 90 kg or more. Treatment will continue until disease progression as defined by RECIST 1.1 criteria, unacceptable side effects, or participant withdrawal. The study includes collection of tumor biopsies at baseline and progression when possible, along with repeated liquid biopsies during the treatment period to analyze biomarkers related to response and resistance. Imaging scans will be conducted every 8 weeks for the first 48 weeks and then every 12 weeks until disease progression. During the study, participants will undergo regular assessments including tumor imaging, laboratory tests, and monitoring for side effects such as oral mucositis and ocular events. Researchers will track progression-free survival as the primary outcome over approximately 24 months. Secondary outcomes include response rates, duration of response, clinical benefit, overall survival, and safety measures. Participants are expected to provide informed consent and comply with study requirements, with close monitoring throughout the treatment period.

Researchers are evaluating the effectiveness and safety of Ifinatamab Deruxtecan I-DXd compared to the treatment chosen by a physician for people with relapsed small cell lung cancer SCLC. This Phase 3 study aims to see if I-DXd can help participants live longer than current treatments, while also examining other effects such as patient-reported outcomes, immune response, and the drugs behavior in the body. Participants will be randomly assigned to one of two groups. One group will receive I-DXd as an intravenous infusion at a dose of 12 mgkg every 21 days until the disease worsens, unacceptable side effects occur, or other stopping reasons arise. The other group will receive one of the standard treatments chosen by their doctortopotecan, lurbinectedin, or amrubicinaccording to local approved dosing guidelines and until treatment discontinuation criteria are met. During the study, participants will be closely monitored with regular imaging and assessments to track tumor response, disease progression, and quality of life using questionnaires. Safety events and immune responses will also be recorded. Pharmacokinetic samples will be collected at specified times to understand how I-DXd behaves in the body. Participants may remain in the study for up to approximately 3.7 years, allowing for long-term evaluation of outcomes and safety.

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Researchers are evaluating MRG007 ARR-217 in an open-label, multi-center phase I trial involving patients with unresectable locally advanced or metastatic solid tumors. The study aims to assess the safety, tolerability, efficacy, and pharmacokinetics of MRG007 in this patient population, including those with colorectal, gastric, or pancreatic cancers who have failed or are intolerant to standard therapies. This research is sponsored by ArriVent BioPharma, Inc. and involves dose escalation, confirmation, and expansion phases. Participants receive MRG007 alone or in combination with Bevacizumab according to the study protocol. The trial uses a sequential study model without randomization or masking. Treatment administration follows specific dosing schedules outlined in the protocol, with evaluations of dose-limiting toxicities and adverse events conducted from baseline through 30 days post-treatment. Objective response rates and other efficacy measures are monitored up to 24 months after starting treatment. Throughout the study, participants undergo evaluations including tumor assessments by RECIST criteria, performance status scoring, and laboratory tests to monitor organ and coagulation functions. Safety is closely tracked via serious and treatment-related adverse events. Pharmacokinetic parameters such as Tmax, Cmax, and antibody responses are also measured. Participants may be followed for up to two years to assess treatment response, disease control, progression-free survival, and overall survival.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with gemcitabine plus cisplatin compared to durvalumab combined with gemcitabine plus cisplatin as a first-line treatment for patients with advanced biliary tract cancer BTC. This phase III, randomized, open-label study aims to improve treatment options for patients with unresectable locally advanced or metastatic BTC who have not received prior therapy for advanced disease. The study focuses on overall survival and other important outcomes over approximately four years. Participants receive either rilvegostomig or durvalumab through intravenous infusion along with chemotherapy drugs gemcitabine and cisplatin. Durvalumab is given every three weeks for up to eight cycles, then every four weeks. Gemcitabine and cisplatin are administered intravenously on Days 1 and 8 of each 21-day cycle. The study compares these two treatment combinations to assess their effects on survival, disease progression, tumor response, and safety. During the study, participants undergo regular assessments including imaging scans like CT or MRI to measure disease status, laboratory tests to evaluate organ function, and evaluations of symptoms and quality of life. Researchers monitor drug levels and immune response markers. The study lasts about four years, with ongoing safety and health status monitoring throughout. Patient-reported symptoms and quality of life are assessed up to 12 weeks after disease progression.